Z-1671-2016 Class II Terminated
FDA device recall Z-1671-2016 was initiated by Ab Sciex on March 25, 2016 and is designated Class II. Reason for recall: Under certain conditions, mass spectrometers may report incorrect quantitative results. The recall status is terminated (terminated May 23, 2016). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2016
- Initiation Date
- March 25, 2016
- Termination Date
- May 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.
Reason for Recall
Under certain conditions, mass spectrometers may report incorrect quantitative results.
Distribution Pattern
Distributed to the state of NC.
Code Information
Serial Numbers: Triple Quad 4500MD LC/MS/MS System BX21081601 BX21101601 BX21091601 BX21111601 BX21121602 BX21131602 BX21141602 BX21151602 QTRAP 4500MD LC/MS/MS System BW20251601 BW20241601 BW20261602